Compliance Notes

May 01, 2012
BioPharm International
By BioPharm International Editors
How to handle and respond to a consent decree.
Apr 01, 2012
BioPharm International
By BioPharm International Editors
FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.
Mar 01, 2012
BioPharm International
By BioPharm International Editors
Focusing on how risk affects the entire organization can improve the business bottom line.
Jan 01, 2012
BioPharm International
Contract organizations must have highly organized teams and plans to accommodate today's audits.
Nov 01, 2011
BioPharm International
By BioPharm International Editors
In a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance.
Sep 01, 2011
BioPharm International
Why SOPs are rarely followed, often cited, and in great need of follow-through.
Jul 01, 2011
BioPharm International
By BioPharm International Editors
Incorporating regulatory requirements into the product life cycle is crucial.
May 01, 2011
BioPharm International
By BioPharm International Editors
A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
Mar 01, 2011
BioPharm International
By BioPharm International Editors
Executive management leadership is essential in the effective implementation of QbD.
Sep 01, 2010
BioPharm International
By BioPharm International Editors
What small biotechs need to know about quality management systems.
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